BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10 CM DUAL EXTENSION

    MDR report key: 1220473 · Received November 4, 2008

    Report

    Report Number
    1627487-2008-00036
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. RESULTS - ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATION. VISUAL EXAMINATION FOUND SLIGHT DISCOLORATION ON EXTENSION HEADER AND EXTENSION LEAD SEGMENT BUT NO OTHER ANOMALIES. EXTENSION PASSED FUNCTIONAL TESTING. ANS, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 5 (REFER TO MANUFACTURER'S REPORT NUMBERS 1627487-2008-00034 FOR DEVICE 1, 1627487-2008-00035 FOR DEVICE 2, 1627487-2008-00037 FOR DEVICE 4, AND 1627487-2008-00038 FOR DEVICE 5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10 CM DUAL EXTENSION SPINAL CORD STIMULATOR SURGICAL LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3341 119017

    Patients

    Seq Age Sex Outcome Treatment
    1